Pediatrics Of Northeastern Pa

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Clinical Supervisor (CS), the laboratory failed to monitor and document room humidity to ensure operating conditions were met for 1 of 1 Magellan LeadCare II Analyzer used to perform whole blood lead (WBL) testing from 02/14/2024 to 1/14/2026. Findings include: 1. The manufacturers operating environment specifications stated: "Operate the analyzer only within the specified humidity range, 12 to 80% relative humidity." 2. On the day of the survey, 1/14/2026 at 12:15pm, the laboratory failed to provide documentation for the monitoring of room humidity to ensure operating conditions were met for the following instrument used to perform WBL testing from 02/14/2024 to 1/14/2026: - 1 of 1 Magellan LeadCare II Analyzer (S/N WLC10619). 3. The CS confirmed the above findings on 01/14/2026 at 1:35 pm. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's College of American Pathologists (CAP) Proficiency Testing (PT) records, lack of documentation, and interview with the Clinical Supervisor (CS), the laboratory failed to document the evaluation and verification activities performed for 1 of 3 CAP PT Bacteriology testing events in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 2024. Findings include: 1. On the day of the survey, 01/14/2026 at 12:45 pm, review of the laboratory's CAP PT records revealed the laboratory failed to document the

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) proficiency testing (PT) records and interview with testing personnel (TP) #1 (CMS 209 personnel #8), the laboratory failed to provide 5 of 6 CAP PT attestation statements for microbiology testing events performed in 2022 and 2023. Findings include: 1. On the day of the survey, 02/14/2024 at 01:47 pm, the laboratory could not provide attestation statements for the following 5 of 6 CAP Microbiology PT events: - 2022 Throat Culture 1st event (D1-A), 2nd event (D1-B) and 3rd event (D1-C) - 2023 Throat Culture 1st event (D1-A) and 3rd event (D1-C) 2. TP #1 confirmed the findings above on 2/14/2024 around 01:47 pm. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency assessment records, competency assessment policy, and interview with testing personnel TP #1 (CMS 209 personnel #8), the laboratory failed to establish and follow policies to assess the competency of 4 of 4 Clinical Consultants (CC) and 2 of 2 Technical Consultants (TC) for their supervisory responsibilities in 2022. Findings include: 1. On the day of the survey, 02 /14/2024 at 01:19 pm, review of the laboratory provided policy "Clinical Consultant /Technical Consultant Responsibilities" stated that "the lab director must complete a competency assessment on all Clinical/Technical Consultants." 2. The laboratory failed to provide competency records on 02/14/2024 for 4 of 4 CC (CMS 209 personnel #2, #3, #4, #5) and 2 of 2 TC (CMS 209 personnel #6, #7) for their supervisory responsibilities in 2022. 3. TP #1 interviewed on 2/14/2024 at 01:19 pm confirmed the findings above. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory competency assessment records and interview with the Laboratory Manager (LM), the laboratory failed to assess the competency assessment of 4 of 5 Clinical Consultants (CC) and 6 of 7 Technical Consultants (TC) for their supervisory responsibilities from 03/07/2020 to 03/07/2022. Findings Include: 1. On the day of survey 03/07/2022 at 10:45 a.m, The LM could not provide competency assessment records for 4 of 5 CC and 6 of 7 TC for their supervisory responsibilities in 2020 and 2021. 2. The LM confirmed the finding above on 03/07/2022 at 01:15 p. m. * Repeated deficiency. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on review of quality control (QC) records and interview with the Laboratory Manager (LM), the laboratory failed to check and document each batch or shipment of Streptococcus Selective Agar (SSA) media for its ability to select or inhibit specific organisms from 03/07/2020 to the date of survey. Findings include: 1. On the day of survey, 03/07/2022 at 11:30 a.m, review of the media QC log revealed, the laboratory failed to document on new lots/shipments of SSA agar media for its ability to select or inhibit specific organisms from 03/07/2020 to the day of survey. 2. Reviewed of CMS 116 revealed that the laboratory analyzed 545 throat cultures annually. 3. The LM confirmed the finding above on 03/07/2022 at 01:15 p.m. D5781

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records, review of procedure manuals and interview with testing personnel (TP) #1, the laboratory failed to follow their own laboratory procedure to assess the competency assessment of 10 of 11 TP analyzing throat cultures and failed to establish a complete procedure to assess the competency assessment 4 of 5 clinical consultants and 6 of 7 technical competency in 2018. Findings Include: 1. The laboratory's testing personnel procedure states, "newly hired employees trained upon the start of work, reviewed six months thereafter, yearly reviews monitored with current employees yearly record kept in the logbook. 2. On the day of survey, 11/14/2019, review of personnel records and the competency assessment procedure revealed: - Yearly competency assessment on 8 of 8 TP who analyzed throat cultures in 2018 were not performed. - 6 month competency assessment on 2 of 2 TP (TP#8 and TP#9) hired June of 2018 who analyzed throat cultures were not performed. 3. The laboratory could not provide a complete procedure to assess the competency assessment 4 of 5 clinical consultants and 6 of 7 technical competency in 2018. 4. 1,528 Throat cultures were analyzed in 2018. 5. TP #1 confirmed the findings above on 11/14/2019 around 9:17 am. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)